Good day Tonia,
The process of "archiving" paper documents (hard-copy documents) has moved from a process of putting them in boxes, cataloguing them, and putting in a dark warehouse somewhere to scanning to an electronic version. And yes be careful with terminology because some words can mean different process or activities to different people. I agree with Glen there needs to be a process (work instruction/procedure) in place defining how hard-copy original documents are scanned, verified for identity, confirmed accuracy and integrity, and the storage medium is secure. Once the digital/electronic version is confirmed then the original paper versions can be destroyed or I like to describe funny as permanently archived. Regulatory agencies, auditors, and investigators these days are used to seeing electronic documents either completely native electronic like a Word document or PDF document digitally signed to documents which are scans of the hard-copy or printed documents which are signed and scanned into PDF. Just make sure there is a process for how these hard-copy documents are put into electronic and maintained according to record controls.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Mar-2022 16:31
From: Glen Park
Subject: Digitizing Original CRFs
Hi Tonia,
You use the term "digitized." The term normally means that a file is converted into a digital form that can be processed by a computer. I suspect you meant scanned? Regardless, converting paper to electronic format (scanned or digitized) requires that a certification process take place before destroying the original paper documents. That means that someone compares the original against the electronic copy and states that all elements of the original are captured in the copy. Then you can destroy the paper copies.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
Original Message:
Sent: 01-Mar-2022 11:35
From: Tonia E. Bryant
Subject: Digitizing Original CRFs
Greetings -
My clinical department has taken original, paper clinical report forms (i.e. source documents) and digitized them. The product lifecycle is still active, so we fully understand the retention requirements under MDR to be product life plus 10 years.
My question is - since the original source documents are now electronic, may we destroy the paper copies? Or, do the original paper copies also have to be retained? Retention of both seems redundant.
Any assistance would be most helpful.
Tonia
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Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
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